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除症状外使用实验室标志物诊断儿童炎症性肠病:个体患者数据的荟萃分析

Use of Laboratory Markers in Addition to Symptoms for Diagnosis of Inflammatory Bowel Disease in Children: A Meta-analysis of Individual Patient Data.

作者信息

Holtman Gea A, Lisman-van Leeuwen Yvonne, Day Andrew S, Fagerberg Ulrika L, Henderson Paul, Leach Stevan T, Perminow Gøri, Mack David, van Rheenen Patrick F, van de Vijver Els, Wilson David C, Reitsma Johannes B, Berger Marjolein Y

机构信息

Department of General Practice, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.

Department of Paediatric Gastroenterology, Sydney Children's Hospital, Randwick, Australia.

出版信息

JAMA Pediatr. 2017 Oct 1;171(10):984-991. doi: 10.1001/jamapediatrics.2017.1736.

Abstract

IMPORTANCE

Blood markers and fecal calprotectin are used in the diagnostic workup for inflammatory bowel disease (IBD) in pediatric patients. Any added diagnostic value of these laboratory markers remains unclear.

OBJECTIVE

To determine whether adding laboratory markers to evaluation of signs and symptoms improves accuracy when diagnosing pediatric IBD.

DATA SOURCES

A literature search of MEDLINE and EMBASE from inception through September 26, 2016. Studies were identified using indexing terms and free-text words related to child, target condition IBD, and diagnostic accuracy.

STUDY SELECTION

Two reviewers independently selected studies evaluating the diagnostic accuracy of more than 1 blood marker or fecal calprotectin for IBD, confirmed by endoscopy and histopathology or clinical follow-up, in pediatric patients with chronic gastrointestinal symptoms. Studies that included healthy controls and/or patients with known IBD were excluded.

DATA EXTRACTION AND SYNTHESIS

Individual patient data from each eligible study were requested from the authors. In addition, 2 reviewers independently assessed quality with Quality Assessment of Diagnostic Accuracy Studies-2.

MEAN OUTCOMES AND MEASURES

Laboratory markers were added as a single test to a basic prediction model based on symptoms. Outcome measures were improvement of discrimination by adding markers as a single test and improvement of risk classification of pediatric patients by adding the best marker.

RESULTS

Of the 16 eligible studies, authors of 8 studies (n = 1120 patients) provided their data sets. All blood markers and fecal calprotectin individually significantly improved the discrimination between pediatric patients with and those without IBD, when added to evaluation of symptoms. The best marker-fecal calprotectin-improved the area under the curve of symptoms by 0.26 (95% CI, 0.21-0.31). The second best marker-erythrocyte sedimentation rate-improved the area under the curve of symptoms by 0.16 (95% CI, 0.11-0.21). When fecal calprotectin was added to the model, the proportion of patients without IBD correctly classified as low risk of IBD increased from 33% to 91%. The proportion of patients with IBD incorrectly classified as low risk of IBD decreased from 16% to 9%. The proportion of the total number of patients assigned to the intermediate-risk category decreased from 55% to 6%.

CONCLUSIONS AND RELEVANCE

In a hospital setting, fecal calprotectin added the most diagnostic value to symptoms compared with blood markers. Adding fecal calprotectin to the diagnostic workup of pediatric patients with symptoms suggestive of IBD considerably decreased the number of patients in the group in whom challenges in clinical decision making are most prevalent.

摘要

重要性

血液标志物和粪便钙卫蛋白用于儿科患者炎症性肠病(IBD)的诊断检查。这些实验室标志物的任何额外诊断价值仍不明确。

目的

确定在评估体征和症状时添加实验室标志物是否能提高儿科IBD诊断的准确性。

数据来源

对MEDLINE和EMBASE自创建至2016年9月26日进行文献检索。使用与儿童、目标疾病IBD和诊断准确性相关的索引词和自由文本词来识别研究。

研究选择

两名评审员独立选择评估一种以上血液标志物或粪便钙卫蛋白对IBD诊断准确性的研究,这些研究通过内镜检查和组织病理学或临床随访在有慢性胃肠道症状的儿科患者中得到证实。排除包括健康对照和/或已知IBD患者的研究。

数据提取与综合

向作者索取每项符合条件研究的个体患者数据。此外,两名评审员使用诊断准确性研究质量评估-2独立评估质量。

主要结果与测量指标

将实验室标志物作为单一测试添加到基于症状的基本预测模型中。结果测量指标包括通过将标志物作为单一测试添加来提高鉴别能力,以及通过添加最佳标志物来改善儿科患者的风险分类。

结果

在16项符合条件的研究中,8项研究(n = 1120例患者)的作者提供了他们的数据集。当添加到症状评估中时,所有血液标志物和粪便钙卫蛋白单独都显著提高了患有和未患有IBD的儿科患者之间的鉴别能力。最佳标志物——粪便钙卫蛋白——使症状曲线下面积提高了0.26(95%CI,0.21 - 0.31)。第二佳标志物——红细胞沉降率——使症状曲线下面积提高了0.16(95%CI,0.11 - 0.21)。当将粪便钙卫蛋白添加到模型中时,被正确分类为IBD低风险的无IBD患者比例从33%增加到91%。被错误分类为IBD低风险的IBD患者比例从16%降至9%。被分配到中度风险类别的患者总数比例从55%降至6%。

结论与意义

在医院环境中,与血液标志物相比,粪便钙卫蛋白为症状增加的诊断价值最大。在对有IBD症状提示的儿科患者进行诊断检查时添加粪便钙卫蛋白,显著减少了临床决策面临挑战最为普遍的患者群体数量。

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